In an announcement on 20 December, the FDA confirmed it has given the green light to the use of Apretude (cabotegravir extended-release injectable suspension) in at-risk adults and adolescents weighing at least 35 kilograms (77 pounds).
The drug is administered with two initiation injections one month apart, with one following every two months thereafter. “Today’s approval adds an important tool in the effort to end the HIV epidemic by providing the first option to prevent HIV that does not involve taking a daily pill,” said Debra Birnkrant, M.D., director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research. “This injection, given every two months, will be critical to addressing the HIV epidemic in the U.S.,